A Phase II Study of Chidamide or Placebo in Combination With Carboplatin and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 8
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Chidamide combined with paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer.
详细描述
The study is to evaluate efficacy which includes the progression free survival (PFS), PFS at 6 months, objective response rate, duration of response rate, overall survival and time to progression, and safety which include adverse events, vital signs, laboratory tests, of the treatment of chidamide plus paclitaxel and carboplatin in patients with advanced non small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histology or cytology confirmed non-small-cell lung cancer,stage IIIb or IV. Newly diagnosed or relapsed after surgery but have not received systemic drug therapy.Adjuvant chemotherapy after surgery should have completed for more than one year at study entry.
- •Aged 18~75 years
- •Epidermal growth factor receptor (EGFR) mutation negative or EGFR status is unknown
- •With at least one measurable lesion
- •White blood cell count≥4×10^9/L,platelet count≥100×10^9/L and hemoglobin≥11g/L
- •Life expectancy >3 months
- •Eastern Cooperative Oncology Group performance status of ≤1 at study entry
- •Women of childbearing age should have pregnancy test negative and would like to conduct birth control during the study
- •Have signed informed consent
排除标准
- •Patients with clinically significant corrected QT interval prolongation, or ventricular tachycardia,or auricular fibrillation, or ≥Grade 2 sino-auricular heart-block,or ≥Grade 3 atrioventricular block,or myocardial infarction within one year, or congestive heart failure,or patients with symptomatic coronary disease which need to be treated by drug
- •The size of fluid area detected by cardiac ultrasonography in cavum pericardium is ≥10mm during diastolic period
- •Organ transplant patients
- •Patients with active bleeding or new thrombotic diseases
- •Patients with body temperature >38.5℃ for more than 3 days
- •Total bilirubin >1.5 fold of upper limit of normal (ULN), ALT/AST>1.5 fold of ULN or serum creatine >1.5 fold of ULN
- •Patients with symptomatic brain-metastasis
- •Pregnant or lactating women
- •Patients with mental disorder
研究组 & 干预措施
Arm 1
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.The chemotherapy cycles are repeated every 3 weeks to a maximum of 4 cycles. Patients also receive Chidamide 20mg orally twice a week until disease progression,or unacceptable toxicities,or withdrawal of consent occurred.
干预措施: Chidamide (Drug)
Arm 1
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.The chemotherapy cycles are repeated every 3 weeks to a maximum of 4 cycles. Patients also receive Chidamide 20mg orally twice a week until disease progression,or unacceptable toxicities,or withdrawal of consent occurred.
干预措施: Paclitaxel (Drug)
Arm 1
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.The chemotherapy cycles are repeated every 3 weeks to a maximum of 4 cycles. Patients also receive Chidamide 20mg orally twice a week until disease progression,or unacceptable toxicities,or withdrawal of consent occurred.
干预措施: Carboplatin (Drug)
Arm 2
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.The chemotherapy cycles are repeated every 3 weeks to a maximum of 4 cycles. Patients also receive placebo orally twice a week until disease progression,or unacceptable toxicities,or withdrawal of consent occurred.
干预措施: Paclitaxel (Drug)
Arm 2
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.The chemotherapy cycles are repeated every 3 weeks to a maximum of 4 cycles. Patients also receive placebo orally twice a week until disease progression,or unacceptable toxicities,or withdrawal of consent occurred.
干预措施: Carboplatin (Drug)
Arm 2
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.The chemotherapy cycles are repeated every 3 weeks to a maximum of 4 cycles. Patients also receive placebo orally twice a week until disease progression,or unacceptable toxicities,or withdrawal of consent occurred.
干预措施: Placebo (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 76 weeks
PFS is measured from the start of treatment until progression or death,whichever is first met
次要结局
- Object Response Rate (ORR)(Response is assessed once every 6 weeks (combination therapy period) for up to 12 weeks, and once every 8 weeks (maintenance therapy period) for up to 64 weeks)
- Time To Progression (TTP) during the maintenance therapy period(From the start date of maintenance therapy until the date of first documented progression, assessed up to 64 weeks)
- Progression-Free Survival Rate at 6 Months (6-M-PFS)(6 months)
- Duration of Response (DOR)(From the first date of response until the date of first documented progression, assessed up to 70 weeks)
- Overall Survival (OS)(From date of randomization until the date of death from any cause, followed for up to 76 weeks)